NCT03983395 - Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer | Biotech Hunter

Enrollment

1

Participants

Timeline

Start Date

April 8, 2020

Primary Completion Date

July 24, 2020

Study Completion Date

July 24, 2020

Conditions

Breast Cancer

Interventions

BIOLOGICAL

ISB 1302 250 ng/kg

ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 250 ng/kg

BIOLOGICAL

ISB 1302 325 ng/kg

ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 325 ng/kg

BIOLOGICAL

ISB 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22

ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 425 ng/kg on D8, D15, D22

BIOLOGICAL

ISB 1302 325 ng/kg-D1;550 ng/kg -D8,D15,D22

ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, D15, D22

BIOLOGICAL

ISB 1302 325ng/kgD1;550 ng/kg D8;700 ng/kgD15,22

ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 700 ng/kg on D15, D22

BIOLOGICAL

ISB 1302 325ng/kg D1;550 ng/kg D8;900 ng/kg D15,22

ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 900 ng/kg on D15, D22

BIOLOGICAL

ISB 1302 escalating doses,1200 ng/kg D15,22

ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 700 ng/kg on D8, and 1200 ng/kg on D15, D22

BIOLOGICAL

ISB 1302 at the MTD and/or RP2D dose

ISB 1302 at the MTD and/or RP2D dose in separate groups in the Q1W and/or the Q2W dose regimen.

Trial Locations (5)

19107

Ichnos Investigational Site 3, Philadelphia

40212

Ichnos Investigational Site 4, Louisville

48201

Ichnos Investigational Site 2, Detroit

85234

Ichnos Investigational Site 1, Gilbert

90048

Ichnos Investigational Site 5, Los Angeles